Cleared Traditional

K970931 - COPALIS TORC TOTAL ANTIBODY ASSAY

K970931 is an FDA 510(k) clearance for COPALIS TORC TOTAL ANTIBODY ASSAY, manufactured by Sienna Biotech, Inc.. The device is a Class 2 Microbiology device with product code LQN cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K970931 · Sienna Biotech, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
48d
Days
Class 2
Risk

K970931 is an FDA 510(k) clearance for the COPALIS TORC TOTAL ANTIBODY ASSAY. Classified as Latex Agglutination Assay, Rubella (product code LQN), Class II - Special Controls.

Submitted by Sienna Biotech, Inc. (Columbia, US). The FDA issued a Cleared decision on April 24, 1997 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sienna Biotech, Inc. devices

FDA 510(k) Submission Details - K970931

510(k) Number K970931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1997
Decision Date April 24, 1997
Days to Decision 48 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 102d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQN Device Classification - Class 2, Special Controls

Product Code LQN Latex Agglutination Assay, Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LQN Latex Agglutination Assay, Rubella

All 9
Devices cleared under the same product code (LQN) and FDA review panel - the closest regulatory comparables to K970931.
COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS
K961784 · Sienna Biotech, Inc. · Oct 1996
MUREX RUB-EX
K954920 · Murex Diagnostics, Inc. · Aug 1996
COLORSLIDER RUBELLA
K952544 · Seradyn, Inc. · Jan 1996
RUBALEX, MODIFICATION
K912391 · Orion Corp. · May 1992
RESUBMITTED MODIFIED RUBALEX
K901637 · Orion Corp. · Apr 1990
RUBALEX (REVISED VERSION)
K861881 · Orion Corp. · Jun 1986